UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013570 |
|---|---|
| Receipt number | R000015853 |
| Scientific Title | Study of comfort and effectiveness of the new catheter fixing method |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2016/02/17 04:56:45 |
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Basic information
Public title
Study of comfort and effectiveness of the new catheter fixing method
Acronym
Effect of medical glue on catheter fixation
Scientific Title
Study of comfort and effectiveness of the new catheter fixing method
Scientific Title:Acronym
Effect of medical glue on catheter fixation
Region
| Japan |
Condition
Condition
surgical patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether fixity of the catheter can be improved by the combination of dressing tape and medical adhesive.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the catheter length of insertion
Key secondary outcomes
patient satisfaction, leakage of injectate, abnormalities of the skin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
combination of dressing tape and medical glue for fixation of catheter
Interventions/Control_2
fixation with only dressing tape with suturing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Of the surgical patients, who undergo catheterization of peripheral nerve block or epidural
Key exclusion criteria
Abnormalities in hemostasis and coagulation, contraindication of epidural anesthesia or peripheral nerve block
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soushi Iwasaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-688-9663
iwasakis@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Murouchi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-688-9663
Homepage URL
g-fields@fc4.so-net.ne.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
